GUEST COLUMNISTS

• Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing

  Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.

• The Complex Anatomy Of An ADC Tech Transfer

  Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

• Unlocking The Future Of Cell And Gene Therapies

  We took the opportunity to speak with some BioPhorum members about issues such as emerging technologies, regulatory challenges, and engagement with regulators in the advanced therapy medicinal products (ATMP) space.

• What Goes Into Restarting A Shelved Orphan Drug Candidate?

  The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

• A Much-Improved Approach For Understanding And Managing Safety Risks

  Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

• CSV Assumes The AI System Sits Still — It Doesn't.

  The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

• July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing

  Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

• In Bioprocessing, Trusted Data Is A Process Variable

  As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.